VANCOUVER, Canada – October 5, 2016 – Tocagen Inc., a clinical-stage, cancer-selective gene therapy company, today announced updated clinical data for Toca 511 (vocimagene amiretrorepvec) in combination with Toca FC (extended-release 5-fluorocytosine) for the treatment of recurrent high grade glioma.
The new data were presented at the 10th International Oncolytic Virus Meeting in Vancouver, Canada by Douglas J. Jolly, Ph.D., executive vice president of research and pharmaceutical development at Tocagen. The podium presentation was titled Molecular analyses and immune activity of Toca 511 a retroviral replicating vector in preclinical models and three ascending dose trials in patients with recurrent high grade glioma.
The presentation included updated response and survival data from Tocagen’s Phase 1, ascending dose study of Toca 511 administered at the time of tumor removal followed by cycles of orally administered Toca FC. Both Toca 511 and Toca FC are investigational agents. In the efficacy evaluable subset of twenty four patients with recurrent glioblastoma or anaplastic astrocytoma who received higher doses of Toca 511 and met the entry criteria for Tocagen’s ongoing Toca 5 trial1, the results were as follows:
|Criteria||Toca 511 & Toca FC (N=24)|
|Median overall survival||14.3 months|
|Overall response, n (%)||5 (20.8)|
(3 CR, 2 PR)*
|Median duration of response, months||20.7|
|Stable disease (SD), n (%)||5 (20.8)|
|Progressive disease, n (%)||14 (58.3)|
|Clinical Benefit Rate, n (%)|
(CR, PR, and SD at 8 weeks)
*Complete response (CR) and partial response (PR). Data cutoff date was September 1st 2016. Responses were assessed using Macdonald Criteria including MRI assessment by independent radiology review and clinical data.
In addition, Toca 511 & Toca FC continued to demonstrate a favorable safety profile and was well tolerated by patients.
“The complete and partial responses occur 6 to 19 months after study entry, consistent with the immunologic mechanism of action observed in our preclinical models,” said Dr. Jolly. “Furthermore, all responding patients have durable responses, remain alive at 21-42 months after study entry, and were clinically stable or improved. We are very encouraged by these data and the potential of this virus treatment for cancer patients.”
The ongoing Toca 5 trial is enrolling patients with recurrent glioblastoma or anaplastic astrocytoma. A current list of participating sites can be found here and a patient/care-giver inquiry form can be submitted here.
1 A phase 2/3 study for patients with first or second recurrence of recurrent glioblastoma or anaplastic astrocytoma; no prior bevacizumab for recurrence; recurrent tumor less than or equal to 5 centimeters.
Tocagen is a clinical-stage, cancer-selective gene therapy company developing first-in-class, broadly applicable product candidates designed to activate a patient’s immune system against their own cancer. The company is developing its lead investigational product candidate, Toca 511 (vocimagene amiretrorepvec) & Toca FC (extended-release 5-fluorocytosine), initially for the treatment of recurrent high grade glioma (HGG), a disease with significant unmet medical need. Tocagen has initiated the Phase 2 portion of a randomized, controlled Phase 2/3 clinical trial of Toca 511 & Toca FC in patients with recurrent HGG, which is designed to serve as a potential registrational trial. More information about the clinical trial can be found at www.tocagen.com/toca5. Tocagen has initiated a clinical trial of Toca 511 & Toca FC in metastatic cancers, including colorectal, pancreatic, lung, breast, renal and melanoma. Tocagen obtained Fast Track designation from the U.S. Food and Drug Administration for Toca 511 & Toca FC as a treatment of recurrent HGG and Orphan drug designation for the treatment of glioblastoma multiforme (GBM), a subset of HGG. Tocagen has received grant support from leading brain cancer foundations, including Accelerate Brain Cancer Cure (ABC2), National Brain Tumor Society (NBTS), American Brain Tumor Association (ABTA), Musella Foundation and Voices Against Brain Cancer (VABC). For more information, visit www.tocagen.com or follow @Tocagen.